Associate Director, Supplier Quality - Hazelwood, United States - bioMérieux SA

bioMérieux SA Hazelwood, United States

6 days ago

Description

Associate Director, Supplier Quality & Incoming QC

Responsible for managing the supplier quality audit program within Quality and ensuring the supplier quality program is correctly tied to manufacturing and product risks.

Responsible for improving how the supplier quality program is used to drive quality into bioMerieux products and manufacturing processes.

Considerations for supplier quality, capability, corrective actions, cost, and bioMerieux/supplier quality oversight must be formally analyzed to ensure appropriate suppliers are selected and monitored.

Lead and work closely with Suppliers, Global Purchasing, Supply Chain, Industrialization, Manufacturing and Engineering in the improvement and management of the supplier quality program.

Interact cross functionally with all levels of the BMX organization and drive improvement in the Suppler Quality program.

Additionally responsible for managing the Incoming Quality Control Departments for the site (Instruments, Reagents). Maintains compliance to Quality System elements, manages budgets and resources, drives continuous improvement and manages projects as appropriate. Recruits, trains and develops personnel, establishes resources and determines actions necessary to accomplish Site Quality Objectives.

Primary Duties:
Perform all work in compliance with company quality procedures and standards. Performs other duties as assigned.
Maintain compliance of Quality System elements applicable to the Site/Function (Supplier Audits, Focused Audits, Supplier Quality Management, Supplier Change Control, Incoming Inspection); Manages inquiries related to Supplier Quality
Manage the Supplier Corrective Action program to ensure suppliers meet performance requirements in quality and service. Ensure Supplier Quality Program considers Risk to bioMerieux manufacturing and final products with applicable supplier oversight.
Manage and Monitor KPIs and Metrics associated with Incoming material performance and productivity of systems. Lead and facilitate team to accomplish deliverables and provides appropriate team support in cross functional audits, projects and activities.
Maintain compliance to quality standards for all new and existing products.
Evaluate prospective suppliers ensuring capabilities and systems align with established requirements.
Evaluate and review supplier quality agreements with Legal and Purchasing to ensure agreements align with established Company requirements.

Manage suppliers and materials to assure applicable systems are in place for the identification, processing and disposition of non-conforming materials provided by suppliers.

Partner with Engineering, Manufacturing , Supply Chain and Suppliers for effective material life cycle management
Recruit, train and develop personnel, establishes resources and determines actions necessary to accomplish Site Quality Objectives

Qualifications:
Training and Education
Requires a Bachelors degree in a scientific or engineering field.
Bachelor's or Master's Degree in Engineering, preferred Mechanical, Electrical, or BioMed
Experience
Minimum of 10 years of relevant industry GMP experience with at least 5 years supervisory experience preferred.
Requires 5+ years experience of supplier quality/qualification and experience in building supplier quality programs, and a solid understanding of the potential sources of supplier quality risk and how to manage risk in a manufacturing environment
6 or more years of experience with Fault Tree Analysis, and/or other risk analysis methods such as FMEA for medical devices
5 or more years of experience in a Medical Device Development or Device Risk Management role
3 or more years of experience with Medical Device Reporting requirements, preferably for the European Union.

Knowledge, Skills, and Abilities:

Expertise in FDA-Quality System Regulation, Canadian-Medical Device Registration, IVD Directive and other applicable country specific regulations) and applicable standards (ISO-9001:2000 & ISO 13485, etc.)

Strong leadership and communication skills, including advanced technical writing skills, are required. Must be a master problem solver / decision maker.
Expertise in conducting quality supplier audits and supporting regulatory inspections is required.
Must have proficiency with Microsoft Office Suite and experience using software tools for trending and analysis.
Requires experience facilitating quality supplier reviews and strong skill collaborating with multi-disciplinary teams.
Certified Quality Engineering (CQE), Certified Quality Auditor (CQA), or Certified Biomedical Auditor (CBA) desired.
Knowledge/experience with risk management preferred

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